A Study of Iron Oligosaccharide in Chronic Kidney Disease Patients

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with chronic kidney disease with a need for parenteral iron.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacosmos A/S
• Treatments: Iron

Criteria

Inclusion Criteria:

Chronic kidney disease patients in pre-dialysis or undergoing dialysis not currently treated with parenteral iron may be included if they meet the following criteria:

• ≥ 18 years of age at screening

• Hb < 110 g/L (6.8 mmol/L)

• Serum ferritin < 800 µgram/L

• Life expectancy beyond 12 months

• Willingness to participate after written informed consent

Chronic kidney disease patients in pre-dialysis or undergoing dialysis willing to switch their current parenteral iron maintenance therapy to iron oligosaccharide may be included if they meet the following criteria:

• ≥ 18 years of age at screening

• Hb ≤ 130 g/L

• Serum ferritin > 200 µgram/L but < 800 µgram/L

• Life expectancy beyond 12 months

• Willingness to participate after written informed consent

Exclusion Criteria:

• Non iron deficiency anaemia

• Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis)

• Drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono- or disaccharide complexes)

• Patients with a history of multiple allergies.

• Decompensated liver cirrhosis and hepatitis (alanine aminotransferase > 3 times normal).

• Acute or chronic infections

• Rheumatoid arthritis with symptoms or signs of active inflammation

• Pregnancy and nursing. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception

• Active bleeding

• Planned elective surgery during the study where significant blood loss is expected

• Participation in any other clinical trial within three months prior to screening